The Upgrade Validation Assistance service is provided through a 3-level offer, respectively called UVA10a, UVA10b and UVA10c.
The main purpose of this service is to speed-up NOTOCORD-hem software upgrade process in the Customer GLP regulated environment.
NOTOCORD proposes the general methodology, shown in the General process chart section, which must be adapted to the Customer needs, and Change Control procedure. The project is built with the Customer’s collaboration; all validation work is based on the Customer’s protocols, needs and risks.
A meeting between the Customer team (QA, IT, users, study directors) and NOTOCORD project leader is mandatory before starting the project, to discuss the quality assurance constraints, to agree on the scope and framework of NOTOCORD actions and to organize together the different phases of the project.
Roles and responsibilities, as well as prerequisites, must be defined before starting the project. During all phases of the project, the Customer remains responsible for reviewing all actions, results, and documentation to ensure regulatory compliance.